Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer

Phase 2

Completed

Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer

Interventions: Drug: irofulven

Registration Number: NCT00053365

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description: OBJECTIVES:

I. Determine the antitumor activity of irofulven in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within at least 6 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 61

Inclusion Criteria

Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- Recurrent or persistent disease
At least 1 unidimensionally measurable target lesion* defined as:
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
- Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients who have not received prior paclitaxel may receive a second regimen containing paclitaxel
Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
Platinum-sensitive disease
- Platinum-free interval** of more than 6 months, but less than 12 months duration, with no clinical evidence of progressive disease after response to platinum
Performance status - GOG 0-2 for patients who received 1 prior therapy regimen
Performance status - GOG 0-1 for patients who received 2 prior therapy regimens
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN
Creatinine normal
Creatinine clearance at least 60 mL/min
No prior congestive heart failure requiring medication
No uncontrolled hypertension within the past 6 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
No history of retinopathy and/or macular degeneration
No neuropathy (sensory and motor) greater than grade 1
No active infection requiring antibiotics
No other illness or condition that would preclude study entry
No prior bone marrow or stem cell transplantation
At least 3 weeks since prior biologic therapy or immunotherapy for malignant tumor
One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) allowed
See Disease Characteristics
At least 3 weeks since prior chemotherapy and recovered
No prior irofulven
No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
At least 1 week since prior hormonal therapy for malignant tumor
Concurrent hormone replacement therapy allowed
See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
No prior radiotherapy to more than 25% of marrow-bearing areas
Recovered from recent prior surgery
At least 3 weeks since any other prior therapy for malignant tumor
No prior anticancer treatment that would preclude study therapy
One prior noncytotoxic cytostatic regimen for recurrent or persistent disease allowed

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (irofulven)	irofulven	Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Primary Outcome Measures

Name	Time	Method
Tumor Response	From entry into study until documented progression or death, assessed up to 5 years.	Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death.
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	From entry into study to death or date of last contact, assessed up to 5 years	Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.